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Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06034353
Recruitment Status : Active, not recruiting
First Posted : September 13, 2023
Last Update Posted : October 16, 2023
Sponsor:
Information provided by (Responsible Party):
Matti Ullah, Hamdard University

Study Description
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Brief Summary:

The purpose of this interventional study is to assess the impact of pharmacist-led cognitive behavioral intervention in epileptic patients. The main questions are:

  1. If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence?
  2. How will the cognitive behavioral therapy impact the quality of life of the patients?

Participants of this study will be provided basic or advanced level counselling and educational material as part of their routine pharmacy visit.

Researchers will compare the two groups (Basic and advanced) to see which of the two groups are better in term of medication adherence and quality of life.


Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Pharmacist-led Cognitive Behavioral therapy Not Applicable

Detailed Description:
The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive behavioral therapy (CBT) to the treatment of epileptic patients can result in better adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication adherence is essential. Missed doses or irregular drug use can increase the frequency of seizures and reduce the effectiveness of treatment. In order to improve medicine adherence rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.
Primary Purpose: Supportive Care
Official Title: Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
Actual Study Start Date : September 22, 2023
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : March 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Medicines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Basic group
Lifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time.
 Behavioral: Pharmacist-led Cognitive Behavioral therapy
Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.
Experimental: Advanced
Lifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided
 Behavioral: Pharmacist-led Cognitive Behavioral therapy
Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.


Outcome Measures
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Primary Outcome Measures :
  1. Medication adherence [ Time Frame: 3 months ]

    Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.

    This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence <6 is poor adherence, and >8 is high adherence.


  2. Quality of life of Epileptic patients [ Time Frame: 3 months ]
    Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.


Secondary Outcome Measures :
  1. Incidence of Drug-Drug Interactions [ Time Frame: 3 months ]
    Drug interactions among epileptic and non-epileptic drug will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervation in both basic and advance groups.

  2. Incidence of Adverse reactions [ Time Frame: 3 months ]

    Adverse reactions of all anti-epileptic drug will be noted while assessing a patient.

    It is used to access the reduction in frequency of Adverse drug reaction after pharmacist intervation in both basic and advance groups.


  3. Rate of seizures per week [ Time Frame: 3 months ]
    While assessing patient no. of seizures per week is asked and noted by the pharmacist. After intervening both basic and advance group impact of intervation is accessed for no. of seizures in the groups.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis.
  • Patients treated for epilepsy with at least one anti epileptic drug, subjects willing to participate in the study with or without other severe co-morbidities were included in the study.

Exclusion Criteria:

  • Pregnant female patients.
  • Patients who provide incomplete information
  • Patients with any terminal disease e.g., end stage renal disease
  • Patients not willing to participate were excluded from the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034353


Locations
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Pakistan
Shifa International Hospital
Islamabad, Pakistan
Sponsors and Collaborators
Hamdard University
Investigators
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Study Director: Matti Ullah, PhD Hamdard University Islamabad Campus
Principal Investigator: Iqra Farooq, MPhil Shifa International Hospital
Study Chair: Muhammad Shafiq, BS. (Hons.) Subhan Medical Trust
Study Chair: Emmama Jamil, MPhil Hamdard University Islamabad Campus
More Information
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Responsible Party: Matti Ullah, Assistant Professor, Hamdard University
ClinicalTrials.gov Identifier: NCT06034353    
Other Study ID Numbers: NA0823
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: October 16, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing patient data will depend on the patient's consent. If the patient doesn't allow to share data with others, we will not be able to share individual data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matti Ullah, Hamdard University:
Cognitive behavioral therapy
Pharmacist
Medication Adherence
Quality of life